MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS; AIRWAY ADAPTOR, NASAL CANNULA

Model Number	M2773A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The customer stated that they were unable to disconnect the ett from the etco2 for suctioning.There was no reported patient incident injury.
Additional Manufacturer Narrative
Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.H3 other text : the adaptor was discarded as medical waste.

• Brand Name: NA
• Common Device Name: AIRWAY ADAPTOR, NASAL CANNULA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8802149
• Report Number: 9610816-2019-00187
• Device Sequence Number: 2693835
• Product Code: MHX
• UDI-Device Identifier: 20884838072118
• UDI-Public: (01)20884838072118
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M2773A
• Device Catalogue Number: 989803144551
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 MO